The European Union (EU) has adapted its legislation on controlling foot-and-mouth disease drawing on the experience gained during the epidemic in the United Kingdom. The new Directive lays down measures to prevent, control and eradicate the disease. It sets out the steps needed to recover foot-and-mouth disease and infection free status without vaccination. The strategy is based on regionalisation and emergency vaccination.

Foot-and-mouth disease (FMD) is a highly contagious viral disease mainly affecting cloven-hoofed animals and is not dangerous for humans.

The epidemic which hit more than 2 000 UK farms in 2001 resulted in considerable economic losses on the rural community. Measures to control foot-and-mouth disease which led to the emergency slaughter of infected herds, restrictions imposed on Community trade and the indirect impact of the epidemic on the environment and tourism in the affected regions had a major cost on the Community as a whole. To ensure this situation does occur again, the Union is adapting its current legislation in order to be able to control this disease more effectively.

SUBJECT MATTER AND SCOPE

This Directive lays down:

the minimum control and eradication measures to be applied in the event of an outbreak of foot-and-month disease of whatever type of virus;

certain preventive measures aimed at increasing awareness and preparedness of the competent authorities and the rural community for the disease.

Members States may take more stringent measures than those provided for in this Directive in order to prevent and control a foot-and-mouth disease epidemic.

CONTROLLING FOOT-AND-MOUTH DISEASE

Notification of foot-and-mouth disease is compulsory. A person working in contact with susceptible animal species in a professional capacity must notify the competent authorities or official veterinarian without delay of the presence or suspected presence of the disease.

Measures in case of suspicion of an outbreak of foot-and-mouth disease

Where a case of foot-and-mouth disease is suspected on a farm, the Member States must ensure that the following measures are carried out:

the official veterinarian activates official investigation arrangements: sampling and laboratory testing;

the competent authority places the holding under official surveillance: a census is made of all animals and they are isolated, all products of animal origin (milk, milk products, meat, meat products, hides and skins, wool, semen, embryos, ova, slurry, manure as well as feedingstuffs and litter) are recorded and an epidemiological inquiry is carried out;

movements onto and off the holding of animals or products of animal origin are banned; movements of persons are subject to strict rules to prevent any spread of the foot-and-mouth disease virus.

In the event of a high density of animals of susceptible species, movements of large numbers of animals or delays in suspect status notifications, the competent authority may establish a temporary control zone in which the above measures apply. The ban on movements of all animals may cover the whole of the territory of a Member State and may be imposed for up to 72 hours.

Provided that it informs the Commission in advance, the competent authority may implement a preventive eradication programme, including the slaughter of animals suspected of being infected.

Measures in case of confirmation of an outbreak of foot-and-mouth disease

As soon as an outbreak of foot-and-mouth disease is confirmed, the Member States must ensure that the following measures are applied immediately on the holding concerned:

all animals of susceptible species on the holding are killed on the spotThe competent authority may order other animals present to be destroyed. The official veterinarian ensures that all appropriate samples needed for the epidemiological inquiry are taken.The inquiry must ascertain, as a minimum, the date on which the outbreak occurred and the possible origin of the virus and identify other affected holdings and movements of persons, vehicles and products of animal origin;

the carcasses of animals which have died or have been killed are processed without delay;

all products of animal origin (milk, milk products, meat, meat products, hides and skins, wool, semen, embryos, ova, slurry and manure, feedingstuffs, litter) present on the holding since the presumed date of introduction of the disease are treated to destroy all traces of the virus;

buildings and vehicles used are cleaned and disinfected under official surveillance in such a way as to reduce any adverse environmental impact as far as possible.

These measures also apply where an outbreak of foot-and-mouth disease is confirmed in a slaughterhouse, border inspection post or transport vehicle. Where an outbreak of foot-and-mouth disease occurs on non-farming premises (laboratory, zoo or wildlife park), all appropriate bio-security measures must be taken to protect the animals from infection.

Restocking of the holding may begin under strict rules and permanent veterinary surveillance 21 days after cleaning at the earliest.

PROTECTION AND SURVEILLANCE ZONES

The following measures apply immediately after an outbreak of foot-and-mouth disease is confirmed:

the competent authority establishes a protection zone based on a minimum radius of three km and a surveillance zone based on a minimum radius of ten km centred on the outbreak of the disease. These zones are marked by signs of sufficient size posted at their entrances;

disease control centres are set up at national and local level. They implement the emergency measures following advice from experts and inform national and Community institutions;

the Member States collaborate in organising the tracing of all susceptible animals and animal products.

The following measures apply to holdings situated in the protection zone:

registration of all holdings and establishment of a census of all animals present on them.

the aforementioned holdings must undergo a veterinary inspection at regular intervals;

animals of susceptible species must remain on the holding except where they are emergency slaughtered in a slaughterhouse outside the protection zone;

fairs, markets and shows for ungulates and artificial insemination are prohibited;

the transport of susceptible animals is banned.

The placing on the market of meat and meat preparations derived from animals of susceptible species produced in the protection zone is prohibited. Unless the products are specially treated and/or subject to strict veterinary control, this ban also applies to meat products, milk and milk products, semen, ova and embryos, hides and skins of such animals and to animal feed, fodder, hay and straw. Sheep wool, ruminant hair, pig bristles and other animal products of the bovine, ovine, caprine and porcine species produced in the protection zone are subject to the same restrictions. In all cases, the distribution of dung originating from this zone is banned.

The competent authority alone is authorised to grant special derogations from these restrictions and issue the additional certification required for intra-Community trade.

The Member States maintain the measures applied in the protection zone until:

at least 15 days elapse after the killing and disposal of all the animals on the holdings affected by FMD;

a survey in all holdings in the protection zone concludes with negative results.

After the removal of the measures applied in the protection zone, the measures applied in the surveillance zone continue to apply for at least two weeks.

The measures laid down for the protection zone apply in the surveillance zone. These include a census of the holdings and the animals on them, a ban on transporting susceptible animals and restrictions on the placing on the market of meat and products of animal origin.

Regionalisation

Where the FMD virus appears to be spreading despite the eradication measures, the Member States affected carry out a thorough epidemiological assessment. Depending on the results, they break down their territory into regions, creating one or more restricted zones and a disease-free zone. In restricted zones, the following measures apply:

control of trade and movements of animals and animal products;

tracing and marking of all products in store;

specific certification of animals of susceptible species and products derived from such animals and health marking in accordance with Community legislation;

tracing, treatment and storage of fresh meat, raw milk and milk products derived from animals of susceptible species produced after the date of estimated introduction of the FMD virus.

VACCINATION

The Member States must ensure that the use of FMD vaccines is prohibited on their territory except as provided for in this Directive.

Trade in animals vaccinated against foot-and-mouth disease is prohibited. Where a protection zone is lifted, vaccinated animals from tested herds may be moved within the Member State provided that a system of traceability ensures that they are excluded from Community trade.

Emergency vaccination

A decision to introduce emergency vaccination may be taken by the Member State affected, on the Commission's initiative or at the request of an exposed neighbouring country, in consultation with the Member State affected. At least one of the following conditions must be met:

outbreaks of foot-and-mouth disease are confirmed and threaten to spread in the Member State;

other Member States are at risk due to the geographical situation of the outbreaks or weather conditions;

other Member States are at risk due to epidemiologically relevant contacts with holdings in the Member State affected;

other Member States are at risk due to the geographical situation or weather conditions in a neighbouring third country.

The criteria for a decision on protective vaccination include: the population density and movements of susceptible animals, the predicted airborne spread of the virus, the Member State's ability to dispose of infected animals, and the origin, distribution and incidence slope of outbreaks.

The conditions for vaccination include a definition of the geographical area in which it is to be carried out, the species and age of the animals to be vaccinated and the duration of the vaccination campaign. The animals treated must be clearly identified and registered and may not be moved under any circumstances.

There are three distinct phases between the beginning of emergency vaccination and reinstatement of FMD-free and infection-free status. Each phase provides for specific measures in the vaccination zone, including movements of animals, fresh meat and other animal products, milk and milk products, a clinical and serological survey and the classification of herds.

Protective vaccination

Member States applying protective vaccination must regionalise the vaccination zone if necessary in close cooperation with neighbouring Member States. They must comply with the rules on hygiene and bio-security and the special rules for protection and surveillance zones described above. Where protective vaccination is carried out, a second surveillance zone at least 10 km wide must be set up.

Suppressive vaccination

Suppressive vaccination is part of an immediate stamping-out strategy and should only be applied to ensure minimum spread of the virus during disposal of infected animals. The Member States must inform the Commission of their decision to apply suppressive vaccination. Suppressive vaccination may be carried out only within a protection zone and on clearly identified holdings.

RECOVERY OF FMD-FREE AND INFECTION-FREE STATUS

Member States affected by a foot-and-mouth disease epidemic and whose territory has been regionalised must take all necessary steps to recover their previous FMD-free and infection-free status.

If they have not resorted to vaccination, they must meet the following requirements:

the control and eradication measures laid down for the protection and surveillance zones have been effective and may be lifted;

at least one of the following conditions applies: the recommendations of the of the OIE are met; at least three months have elapsed after the last recorded outbreak of foot-and-mouth disease.

If vaccination has been used, Member States can recover their status subject to the following conditions:

the control and eradication measures laid down for the protection and surveillance zones have been effective and may be lifted;

they have implemented the measures laid down for the three phases following the beginning of the vaccination campaign;

at least one of the following conditions applies: the recommendations of the Animal Health Code of the OIE are met; at least three months have elapsed since the slaughter of the last vaccinated animal and serological surveillance has been carried out; at least six months have elapsed since the last outbreak of foot-and-mouth disease or the completion of emergency vaccination, whichever event occurred later.

PREVENTIVE MEASURES

Laboratories and establishments handling FMD virus

Live foot-and-mouth disease virus, its genome, antigens or vaccines may only be handled in laboratories that are approved and strictly controlled. An official list of these establishments is drawn up and updated regularly.

Each Member State designates a national reference laboratory with sufficient material and human resources, whose main task is to confirm whether foot-and-mouth disease is present or not. It also coordinates diagnosis standards and methods at national level and carries out antigen identification and genome characterisation for the virus responsible for any new outbreak. A national reference laboratory may perform these tasks for one or more Member States. A Community reference laboratory is also designated.

Diagnosis of foot-and-mouth disease

The national laboratories apply diagnostic tests and standards meeting the requirements of the OIE "Manual of Standards for Diagnostic Tests and Vaccines". Standardised inactivated antigens of all seven serotypes and strains of the virus are available from the World Reference Laboratory.

Contingency plans and real-time alert exercises

The Member States are to draw up a contingency plan specifying the national measures to be implemented in the event of an outbreak of foot-and-mouth disease. It is designed to maintain a high level of FMD awareness and environmental protection. It provides for access to the necessary human and technical resources and coordination with neighbouring Member States. The European Commission delivers an opinion on the plans, which are reviewed every five years.

Real-time alert exercises must be carried out at least twice every five years in close collaboration with the competent authorities of neighbouring Member States. The Commission is to be informed of the results of these exercises.

Antigen and vaccine banks

Under their contingency plans, the Member States can establish or maintain national antigen and vaccine banks for the storage of reserves for emergency vaccination in accordance with Directive 2001/82/EC on the Community code relating to veterinary medicinal products.

This Directive creates a Community antigen and vaccine bank is to be established. For security reasons, information on the quantities of antigens and authorised vaccines stored is confidential. The manufacturer of the antigen contracted by the Commission must be able to supply up to one million doses of vaccine within four days and up to four million doses of vaccine within 10 days. All Member States have access to the Community bank on request. Where it is in the interest of the Community, the Commission may offer assistance to third countries.

Additional prevention and control measures

The Member States ensure that the feeding of catering waste to animals of susceptible species is prohibited in accordance with Regulation (EC) No 1774/2002 on animal by-products not intended for human consumption.

Where wild animals are suspected of being infected with foot-and-mouth disease, the Member State concerned must take the necessary measures to confirm or rule out the presence of the disease, in particular by means of laboratory testing. As soon as it is confirmed that a wild animal has foot-and-mouth disease, the Member State concerned must take the necessary measures to limit the spread of the disease and draw up an eradication plan. Owners of these animals and hunters are to be kept informed of the situation.

Penalties

The Member States must lay down rules on penalties applicable to infringements of national provisions. They must be effective, proportionate and dissuasive and notified to the Commission by 30 June 2004.